DigiLine
GUDID D769DGLIAL0
DigiLine Aligner
PARK DENTAL RESEARCH CORP
Orthodontic progressive aligner| Primary Device ID | D769DGLIAL0 |
| NIH Device Record Key | d42a6b4c-77f8-4785-9572-a3a3d69aa371 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DigiLine |
| Version Model Number | DGL-IAL |
| Company DUNS | 011441508 |
| Company Name | PARK DENTAL RESEARCH CORP |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-243-7372 |
| info@pdrus.com | |
| Phone | 1-800-243-7372 |
| info@pdrus.com | |
| Phone | 1-800-243-7372 |
| info@pdrus.com | |
| Phone | 1-800-243-7372 |
| info@pdrus.com | |
| Phone | 1-800-243-7372 |
| info@pdrus.com | |
| Phone | 1-800-243-7372 |
| info@pdrus.com | |
| Phone | 1-800-243-7372 |
| info@pdrus.com | |
| Phone | 1-800-243-7372 |
| info@pdrus.com | |
| Phone | 1-800-243-7372 |
| info@pdrus.com | |
| Phone | 1-800-243-7372 |
| info@pdrus.com | |
| Phone | 1-800-243-7372 |
| info@pdrus.com | |
| Phone | 1-800-243-7372 |
| info@pdrus.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D769DGLIAL0 [Primary] |
FDA Product Code
| NXC | Aligner, Sequential |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-07 |
| Device Publish Date | 2024-07-30 |
Devices Manufactured by PARK DENTAL RESEARCH CORP
| D769CMIAL0 - Clear Moves | 2025-12-24 Clear Moves Aligner |
| D769O3D0 - Orchestrate 3D | 2025-07-25 Orthodontic Software |
| D76980281 - IMTEC | 2025-05-22 Dispensing Gun |
| D769IMP90230 - IMTEC | 2025-05-22 2.0/3.3mm Paralleling Pins |
| D769IMP9025DL0 - IMTEC | 2025-05-22 StarVent MT Latch Driver |
| D769IMP90450 - IMTEC | 2025-05-22 3.75/4.2mm Paralleling Pin |
| D769IMXP9025DL0 - IMTEC | 2025-05-22 StarVent XP Latch Driver |
| D769JGUN10 - IMTEC | 2025-05-22 Univisal Dispensing Gun |
Trademark Results [DigiLine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIGILINE 97501031 not registered Live/Pending |
PDR/Orchestrate LLC 2022-07-13 |
 DIGILINE 79073679 not registered Dead/Abandoned |
Velpa Enveloppen B.V. 2009-08-06 |
 DIGILINE 78168205 2907196 Dead/Cancelled |
Digi International Inc. 2002-09-26 |
 DIGILINE 78013025 not registered Dead/Abandoned |
Kirchoff, Timothy Paul 2000-06-16 |
 DIGILINE 77800840 not registered Dead/Abandoned |
SPICERS 2009-08-10 |
 DIGILINE 75710687 2931025 Live/Registered |
Pfeiffer Vacuum GmbH 1999-05-20 |
 DIGILINE 75083316 2043479 Dead/Cancelled |
Southwestern Bell Telephone Company 1996-04-03 |
 DIGILINE 74499614 not registered Dead/Abandoned |
ACC Corp. 1994-03-14 |
 DIGILINE 72392585 0925506 Dead/Expired |
ITEK CORPORATION 1971-05-20 |
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